Warnings / Safety Instructions - Medela Thopaz Mode D'emploi

Warnings / Safety instructions

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Thopaz is approved exclusively for use as described in these instructions. Medela can only
guarantee the safe functioning of the system when Thopaz is used in combination with the
original Medela accessories (canisters, tubing sets, carrying strap, mains adapter, docking sta-
tion).
Thopaz is EMC-tested in conformity with the requirements of IEC 60601-1-2:2007 and can be
used in the vicinity of other EMC-tested devices that fulfil the requirements as outlined in the
IEC 60661-1-2 standard. Untested HF sources, radio networks or the like can impair the func-
tion of the device and should not be operated in the vicinity of Thopaz.
Please read and observe these warnings and safety instructions before putting into
operation.
Warnings
• Before connecting Thopaz to the power supply, please verify that the supply voltage corre-
sponds to that given on the device specification plate.
• Data transfer via USB is not possible while the pump is connected to the patient.
• The device is not suitable for use while bathing, showering or in a hazardous explosive
environment.
• Do not use Thopaz in MRT (Magnetic Resonance Tomography).
• Do not dry Thopaz with microwaves.
Safety instructions
• Thopaz must remain in an upright position during use.
• The patient should be regularly monitored according to internal hospital guidelines.
• The pressure range to be set must be determined by a physician in accordance with the
age and weight of the patient.
• The secretions gathered must be monitored more regularly or frequently in accordance with
the age and weight of the patient.
• Thopaz is a medical device that requires special safety precautions and must be installed
and placed in operation in accordance with the attached EMC information. Portable and
mobile RF communication devices (mobile telephones) can affect Thopaz.
• A replacement device must always be available for patients for whom a breakdown of the
device can lead to a critical situation.
• In none of the following cases may Thopaz be placed in operation:
- if the power cord or plug is damaged
- if the device is not functioning properly
- if the device is damaged
- if the device has apparent safety defects.
• Keep the power cord away from hot surfaces.
• Keep the AC adapter connector away from moisture.
• Disconnection from the power supply is achieved by unplugging the mains adapter.
These instructions for use must be kept for later reference.
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